Palliative care program effectiveness research: developing rigor in sampling design, conduct, and reporting

Research on palliative care presents some unique sampling challenges. The purpose of this paper is to articulate the sampling challenges that palliative care researchers face during phases of study design, conduct, and the reporting of results. Challenges include identifying a target population, avoiding selection bias in the face of clinician and patient denial of serious illness, developing eligibility criteria for a seriously ill population, minimizing high patient refusals due to illness, and accurate reporting of all screened and eligible participants. These challenges are explored within the context of a randomized clinical trial testing a palliative care intervention. Suggestions for improving scientific rigor in sampling design include 1) defining a target population that is consistent with research goals; 2) identifying eligibility criteria that are objective and understandable to clinicians to yield the desired sample; and 3) reporting results about the target population, sample eligibility/exclusions, and participation using standardized criteria.     

Research ethics, informed consent, and participant recruitment

PURPOSE/OBJECTIVES: This analysis explores ethical issues and challenges in participant recruitment. BACKGROUND/RATIONALE: The clinical nurse specialist (CNS) as researcher faces many issues and challenges, including ethical issues of informed consent. Balancing participant expectations of care with the research purpose is often challenging. DESCRIPTION OF THE ANALYSIS: This analysis synthesizes literature in key areas related to participant recruitment. Medline, CINAHL, and hand search techniques were used to collect relevant materials for this analysis. OUTCOMES: Key issues related to ethics and informed consent included readability of consent documents, education level, relationships between participants and health care providers, therapeutic misconception, and illness severity. Related issues include compensation of participants, recruitment of special populations, and the role of clinical research associate. INTERPRETATION/CONCLUSIONS: The CNS faces considerable ethical and logistical challenges in any research study. Strategies to support the CNS as researcher are available. IMPLICATIONS FOR NURSING PRACTICE: Increased awareness of ethical issues and challenges in recruitment is important for the CNS to creatively design strategies to enhance recruitment and retention in research studies.     

A celebration of hospice and palliative care in St Petersburg,Russia

Abstract

Introduction

Delirium research in palliative care, particularly in the dying phase, is possible but is frequently met with ethical and methodological challenges. This paper describes the challenges faced in a previous delirium screening study.

Methods

Within 72 hours of admission to an acute inpatient specialist palliative care unit, 100 consecutive patients over 18 years of age with advanced cancer were invited to be screened for delirium using validated screening tools.

Results

Of the 100 consecutive admissions, 49 patients were unable to participate including 7 who did not meet the inclusion criteria and 9 (6 families and 3 patients) who withheld consent. The remaining 33 patients were more unwell and closer to death than those who were recruited. Reasons for non-participation included being too unwell/gate keeping (10), unresponsive (9), died (2) or discharged (3) before recruitment, and exceeding the 72 hour time limit (9).

Conclusion

Gate keeping and physical condition of patients were the main obstacles to recruitment and is consistent with barriers faced in previous studies involving palliative care and dying patients. While it is possible and necessary to conduct studies in palliative care, including the terminal phase, as reflective practitioners, we must maintain the balance between the demands for evidence-based practice and our compassion and respect for our most vulnerable of patients.     

Design of trials with dying patients: a feasibility study of cluster randomisation versus randomised consent

There is little rigorous evidence to underpin clinical guidelines for palliative care. However, research in palliative care is difficult, especially with dying patients. Consent is a major issue, since staff do not wish to invite dying patients to participate in trials. We, therefore, conducted a feasibility study in two units within the North West Wales NHS Trust. We explored two novel approaches to research in palliative care -cluster randomisation and randomised consent. All patients admitted to the two units during the study were asked for permission to use their data for research. We allocated the two units, at random, to use cluster randomisation or randomised consent for three months, and then to crossover to the other design. Of 24 patients dying during cluster-randomised phases, 13 gave consent on admission to use their data and were, thus, eligible to enter the trial; however, defined eligibility criteria reduced these to six active participants. Of 29 patients dying during randomised consent phases, seven gave consent on admission to use their data; although two were eligible for randomisation, neither entered the trial. We judge that cluster randomisation is the more effective design for research with dying patients. Computer simulation, based on data from 1500 dying patients on the Welsh Integrated Care Pathway, shows that crossover cluster trials need much smaller samples than simple cluster trials. Furthermore, this study has shown that crossover cluster trials are entirely feasible. We recommend a 'definitive' trial to test the crossover design more widely.     

Diagnosis and management of neuropathic pain in palliative care

Neuropathic pain can be distressing and difficult to treat, and remains a problem for a significant proportion of palliative care patients. This article considers the identification and assessment of neuropathic pain, and highlights some of the challenges specific to the palliative care population. Further discussion includes definitions, pathophysiology and implications for nursing practice.     

It just didn't work: the realities of quality assessment in the English health care context

AIMS: Assessment of care quality is integral to health and palliative care provision and there is a need to develop and implement outcome measures to assess quality. This study aimed to: (1) describe the implementation of a palliative care outcome measure in non-specialist palliative care settings and (2) to understand the implementation of the measure. METHOD: Twenty-five non-specialist palliative care settings were purposely sampled and invited to implement a palliative care outcome measure. Fifteen settings agreed to take part. The research team provided training and support in the use of the measure. Data were collected on actual use of the measure and, via interviews with patients and nurses, on their experiences. RESULTS: The number of assessments was low (21 patients assessed against an anticipated minimum of 240). The analysis of nurses' accounts identified important considerations in understanding the low response. Although nurses saw the implementation of the outcome measure as bringing opportunities for themselves, including their own professional development, and for the organisations they represent, including raising organisational profiles, there were a number of factors that acted as impediments. These include: perceived time to administer the paperwork; competence and confidence in recruiting patients and proceeding with informed consent; concerns about the effects of completing the measure with very ill patients; and the effects of nurses raising palliative care issues on their relationships with patients. CONCLUSIONS: It is difficult to integrate outcome measures into routine clinical practice. Future interventions should consider how to tailor the implementation of outcome measures within existing working structures and provide education and training to enable nurses to deal with potentially sensitive palliative care issues.     

Multisite randomized controlled trials in health services research: scientific challenges and operational issues

Although well-designed randomized controlled trials (RCT) provide the strongest evidence regarding causation, only relatively recently have they been used by health services researchers to study the organization, delivery, quality, and outcomes of care. More recent yet is the extension of multisite RCTs to health services research. Such studies offer numerous methodological advantages over single-site trials: (1) enhanced external validity; (2) greater statistical power when studying conditions with a low incidence or prevalence, small event rate in the outcome (eg, mortality), and/or large variance in the outcome (eg, health care costs); and (3) rapid recruitment to provide health care organizations and policy makers with timely results. This paper begins by outlining the advantages of multisite RCTs over single-site trials. It then discusses both scientific challenges (ie, standardizing eligibility criteria, defining and standardizing the intervention, defining usual care, standardizing the data collection protocol, blinded outcome assessment, data management and analysis, measuring health care costs) and operational issues (ie, site selection, randomization procedures, patient accrual, maintaining enthusiasm, oversight) posed by multisite RCTs in health services research. Recommendations are offered to health services researchers interested in conducting such studies.     

Exploring the role of community palliative care nurse specialists as educators

In the UK the clinical nurse specialist role (CNS) has evolved in an uncoordinated manner resulting in a broad job remit, with clinical, managerial, research and educational elements. CNSs working in specialist palliative care are expected to contribute to the delivery of education but many have received no formal training to support them in this aspect of their role. There has been limited research exploring the role the community palliative care CNS in providing education, making this study timely. AIM: The aim of this study was to explore the role of the community palliative care CNS as educator. METHOD: Hermeneutic phenomenology, using semi-structured interviews with a convenience sample of eight community palliative care CNSs was the approach used. Formal ethical approval was obtained and all participants provided written informed consent. Colaizzi's framework for analysis provided a structured and transparent approach to data analysis. A summary of the findings were verified by the participants to enhance the credibility of interpretation presented here. RESULTS: Data analysis identified three main themes; conflict of expectations, credibility as a teacher and making the education role work. This study highlighted a team approach may address the conflict of expectations between the role specifications and practice reality. CONCLUSION: The CNS has a role in education. However for some CNSs, providing informal education rather than formal education may be appropriate. If the community palliative care CNS provides formal education, they require the knowledge and skills to deliver it effectively. The role of the CNS in palliative care education in the community should respond to personal, professional and local needs.     

Challenges in conducting end-of-life research in critical care

Critical care units present some unique challenges to the researcher, especially when the research topic of interest is related to end-of-life care. The purpose of this article is to address some of the methodological and practical issues related to conducting end-of-life research in the critical care setting. Recruitment barriers include gaining access to a clinical site, gaining access to patients, and prognostic uncertainty. Additional barriers include challenges related to informed consent, data collection, the research team, and ethical considerations. Strategies are described that can be used to guide researchers to conduct end-of-life research successfully in critical care.     

The impact of conducting a regional palliative care clinical study

End-of-life care must be informed by methodologically rigorous, high-quality research, but well-documented barriers make the conduct of palliative care clinical trials difficult. With careful consideration to study design and procedures, these barriers are surmountable. This paper discusses the approach used in a large scale, randomised, controlled trial of service-based interventions in a regional palliative care service in South Australia, and the impact of this trial on palliative care research more broadly, the changes to the service in which it was conducted, and on health policy beyond palliative care. The Palliative Care Trial evaluated three interventions in a 2 x 2 x 2 factorial cluster randomised design: case conferences, general practitioner education, and patient education. Main outcomes were performance status, pain intensity, and resource utilisation. A total of 461 patients were enrolled in the study. Pre-study planning and piloting is crucial, and accurately estimated withdrawal and death rates in the study. Other study design elements that facilitated this research included assessment of three interventions at one time, a dedicated recruitment role, a single clinical triage point, embedding data collection into routine clinical assessments, and meaningful outcome measures. Recruitment and retention of participants is possible if barriers are systematically identified and addressed. This study challenged and developed the research culture within our clinical team and subsequently translated into further research.     

"Pain talk" in hospice and palliative care team meetings: an ethnography

BACKGROUND: Specialist palliative care nurses have considerable expertise in pain management and this expertise can contribute to tension in the boundary between specialist nurses and non-specialist doctors. OBJECTIVES: This article reports on how specialist palliative care nurses contribute to team talk about pain and the rhetorical strategies they use to develop their reputation and credibility in pain management. DESIGN AND SETTINGS: This is an ethnographic study involving the collection of naturally occurring data from eight palliative care team meetings. The study is concerned with team meetings in hospice, community and hospital palliative care settings. METHODS: Data was collected by audio recording eight team meetings in hospice, hospital and community palliative care settings. The data were analysed using a grounded theory approach followed by application of the tools of discourse and conversation analysis. RESULTS: The findings indicate that specialist palliative care nurses use rhetorical strategies such as contrastive rhetoric, telling atrocity stories, veiled criticism and neutralism as a platform for building a reputation in managing pain. Furthermore they situate their expertise in pain management by direct contrast with problems related to non-specialist practice in pain management. CONCLUSIONS: The team meetings are a safe place, a collegial setting for specialist nurses to challenge non-specialist medical practice and to manage the specialist/non-specialist boundary. The findings have implications for further research related to the specialist nurse/non-specialist doctor boundary and for education of specialist nurses and GPs.     

Constipation in Palliative Care: What Do We Use as Definitions and Outcome Measures?

ContextAdvances in the management of constipation in palliative care remain hindered by the lack of agreed-upon diagnostic criteria.ObjectivesThe objective of this work was to emphasize this issue by systematically examining the eligibility and primary outcome measures in studies of constipation in the hospice and palliative care population.MethodsA palliative care-specific electronic literature search was undertaken using the validated domain filter “palliative care” and topic filter “constipation” in CareSearch (www.caresearch.com.au), which interrogates PubMed in real time (1965–2011). Studies were included if they were primary reports of the treatment of constipation in a palliative care setting. Articles could be prospective or retrospective; randomized controlled trials, cohort studies, or case series.ResultsTwenty articles on the palliative care population were included in which there were six different definitions of constipation. Only 12 of 20 articles used their cited definitions of constipation as the studies' primary outcome measures and four of four blinded, randomized, controlled trials. Articles that used the time between bowel actions or the use of laxatives as the definition of constipation were most likely to report outcomes based on these criteria.ConclusionConstipation is a significant problem in palliative care; however, not having an agreed-upon definition limits research initiatives and the ability to apply these results clinically to people with constipation. Four domains are suggested as pivotal to the diagnosis: any life-long history of constipation (using the Rome Criteria), evaluation of physical changes that may cause or worsen constipation, the subjective sensation (such as feelings of incomplete defecation or bloating or fullness), and objective changes (such as frequency or consistency of stools).     

Knowledge translation: An interprofessional approach to integrating a pain consult team within an acute care unit

Management of pain in the frail elderly presents many challenges in both assessment and treatment, due to the presence of multiple co-morbidities, polypharmacy, and cognitive impairment. At Baycrest Health Sciences, a geriatric care centre, pain in its acute care unit had been managed through consultations with the pain team on a case-by-case basis. In an intervention informed by knowledge translation (KT), the pain specialists integrated within the social network of the acute care team for 6 months to disseminate their expertise. A survey was administered to staff on the unit before and after the intervention of the pain team to understand staff perceptions of pain management. Pre- and post-comparisons of the survey responses were analysed by using t-tests. This study provided some evidence for the success of this interprofessional education initiative through changes in staff confidence with respect to pain management. It also showed that embedding the pain team into the acute care team supported the KT process as an effective method of interprofessional team building. Incorporating the pain team into the acute care unit to provide training and ongoing decision support was a feasible strategy for KT and could be replicated in other clinical settings.     

Leveraging Real-World Data for the Selection of Relevant Eligibility Criteria for the Implementation of Electronic Recruitment Support in Clinical Trials

Background  Even though clinical trials are indispensable for medical research, they are frequently impaired by delayed or incomplete patient recruitment, resulting in cost overruns or aborted studies. Study protocols based on real-world data with precisely expressed eligibility criteria and realistic cohort estimations are crucial for successful study execution. The increasing availability of routine clinical data in electronic health records (EHRs) provides the opportunity to also support patient recruitment during the prescreening phase. While solutions for electronic recruitment support have been published, to our knowledge, no method for the prioritization of eligibility criteria in this context has been explored. Methods  In the context of the Electronic Health Records for Clinical Research (EHR4CR) project, we examined the eligibility criteria of the KATHERINE trial. Criteria were extracted from the study protocol, deduplicated, and decomposed. A paper chart review and data warehouse query were executed to retrieve clinical data for the resulting set of simplified criteria separately from both sources. Criteria were scored according to disease specificity, data availability, and discriminatory power based on their content and the clinical dataset. Results  The study protocol contained 35 eligibility criteria, which after simplification yielded 70 atomic criteria. For a cohort of 106 patients with breast cancer and neoadjuvant treatment, 47.9% of data elements were captured through paper chart review, with the data warehouse query yielding 26.9% of data elements. Score application resulted in a prioritized subset of 17 criteria, which yielded a sensitivity of 1.00 and specificity 0.57 on EHR data (paper charts, 1.00 and 0.80) compared with actual recruitment in the trial. Conclusion  It is possible to prioritize clinical trial eligibility criteria based on real-world data to optimize prescreening of patients on a selected subset of relevant and available criteria and reduce implementation efforts for recruitment support. The performance could be further improved by increasing EHR data coverage.     

Emergency medicine physicians' perspectives of providing palliative care in an emergency department

This study describes emergency physicians' perspectives on the challenges and benefits to providing palliative care in an academic, urban, public hospital in Los Angeles. Participants underwent a semi-structured interview on their training and experiences related to palliative care, perceptions of providing palliative care, and their recommendations for education and training in this area. Overall, respondents felt that palliative care is not prioritized appropriately, leading patients to be unaware of their options for end-of-life care. Providing educational materials and courses that have been developed from the ED perspective should be included in ongoing continuing medical education. Having a palliative care team that is responsive to the needs of the ED will further enhance collaboration with the ED. Future research should focus on understanding the range of benefits to having palliative care in the ED.     

The ethics and practicalities of consent in palliative care research: an overview

In order to ensure that further developments and improvements are made in palliative care, research is essential. Palliative care is no different from other specialities in that it needs a scientific foundation on which to base its practice. Research in palliative care is particularly difficult, however, because of the population under study. Research in palliative care presents a 'minefield' of ethical issues. One of the major issues is how to obtain informed consent from patients. This article discusses the practical and ethical issues surrounding consent for quantitative research in palliative care, and offers some guidance to health professionals considering the issue with patients.     

Analysis of missing data in palliative care studies

This report discusses the general problem of the analysis of data that could include missing values. In the palliative care setting, the data may not be missing at random, but instead be related to the outcome of interest, and therefore the use of standard statistical procedures may be problematic. This study summarizes differing results that were found when using three simple methods for estimating missing data in an example data set testing for differences in the use of morphine or methadone for relief of pain. Differences in the conclusions are discussed and recommendations are made to improve the reporting of studies with missing data.     

Involvement and (potential) influence of care providers in the enlistment phase of the informed consent process: the case of AIDS clinical trials

This article draws on ethnographic field data collected during an investigation of the informed consent process and AIDS clinical trials. It describes the involvement of care providers (physicians, nurse practitioners, physician assistants) during the enlistment, or recruitment, phase of the informed consent process. It shows that sometimes care providers are involved in the receipt, evaluation and distribution of information on clinical trials through their interactions with research professionals and patients. It suggests that the involvement of care providers has the potential to influence the informed consent process. Some of the ethical and practice considerations of this are discussed.